Maquet Critical Care AB

Address:ROENTGENVAGEN 2,SOLNA Stockholm,SE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilator, Continuous, Facility Use (CBK) (9) Gas-Machine, Anesthesia (BSZ) (1)

Premarket Exempt

No Yes

Clear

USER INTERFACE HOLDER - 07325710000717 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

HUMIDIFIER HOLDER - 07325710000724 Catalog Number :

Device Description : Sales kit containing:1 pc Humidification holder assembly 073257100042581 pc Rail Sales kit containing:1 pc Humidification holder assembly 073257100042581 pc Rail clamp 07325710004265

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

SHELF BASE - 07325710000748 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

PENDANT BED/HOLDER - 07325710000762 Catalog Number :

Device Description : Sales kit containing1pc Universal holder 073257100042891 pc Table attachement 07 Sales kit containing1pc Universal holder 073257100042891 pc Table attachement 07325710004272

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

MOBILE CART - 07325710000786 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Servo-i Base Unit - 07325710000823 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Base Unit SERVO-n - 07325710001042 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

BASE UNIT SERVO-U - 07325710001110 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Servo-s Base Unit - 07325710001127 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

Vaporizer Isoflur. Maquet filling - 07325710001134 Catalog Number :

Device Class : 2

Duns Number: 632707092

Premarket Exempt : No

Product Code : BSZ

Prescription Use : No

Device Count : 1

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